Variable surface breast implant

ABSTRACT

A variable textured breast implant is provided including a front surface that has a porous texture and a back surface having a smooth or less porous texture than the front surface texture.

This application is a continuation-in-part of U.S. patent applicationSer. No. 14/106,524, filed on Dec. 13, 2013, which claims priority andthe benefit of U.S. Provisional Patent Application No. 61/736,687, filedDec. 13, 2012, the entire disclosure of each of these applications beingincorporated herein by this reference.

The present invention generally relates to breast implant technology andmore specifically relates to a variable surface breast implant.

BACKGROUND

Soft tissue implants are commonly used for a wide variety of clinicaland cosmetic purposes. One use involves reconstructive applications thatrebuild and restore a body part or structure to correct deformities fromcongenital anomalies, trauma, cancer, infections, disease, or medicationside effects. The soft tissue implant serves to replace lost tissue,provide aesthetic improvement, support surrounding tissue and/or tomaintain the normal appearance of the body. The restoration of a normalappearance has a significant beneficial psychological effect onpost-operative patients, alleviating much of the shock and depressionthat often follows extensive surgical procedures. Another use involvesaugmentation applications that alter a body part or structure usually toimprove its cosmetic or aesthetic appearance. Augmentation of theappearance also has beneficial psychological effects that improveself-esteem, well-being, and confidence of an individual.

The use of implantable prostheses for breast shaping, for example, forbreast reconstruction following traumatic or surgical loss of breasttissue or, electively to increase volume of the breast is well known.Typically, the prosthesis or implant comprises of a soft, flexibleenvelope containing a liquid or gelatinous material. The envelope iscommonly made from silicone or other bio-compatible polymer with varyingdegrees of elastic memory and permeability. These prostheses are filledwith saline, and silicone oil or gel to mimic the tone and feel ofnatural breast tissue.

Capsular contracture is an adverse event related to breast implantsurgery. It is believed to be a result of the immune system response tothe presence of a foreign material in the body. A normal response of thebody to the presence of a newly implanted object, for example a breastimplant, is to form periprosthetic tissue, sometimes in the form of acapsule containing collagen fibers around the implant. Capsularcontracture occurs when the capsule begins to contract and constrict theimplant. This contracture can be discomforting or even extremelypainful, and can cause distortion of the appearance of the augmented orreconstructed breast.

The exact cause of contracture is not known. However, some factors thatmay influence contracture include bacterial contamination of the implantprior to placement, submuscular versus subglandular placement, andsmooth surface implants versus textured surface implants, the type ordegree of texture on the implant surface, and bleeding or trauma to thearea.

Surface texturing has been shown to reduce capsular contracture whenimplants are placed in the subglandular position compared to what areknown as “smooth” surface implants. In other words, it is generally wellknown in the art that patients fitted with textured implants are lesslikely to exhibit contracture, relative to patients fitted withnon-textured or smooth surface implants placed subglandularly. However,there is still a need for a textured implant that is specificallydesigned to encourage optimal tissue integration in the most beneficiallocation, and potentially reduce capsule formation and collagen fiberalignment described herein.

Conventional manufacturing processes for textured implants include theapplication of dissolvable particles onto a tacky elastomeric surface ofan implant shell and subsequent removal thereof, leaving a dimpled ortextured surface in the elastomer. Alternating layers of particles andelastomer provide a way to produce a textured surface defined by aporous surface having a desired depth.

There remains a need for better breast implants with textured regions.

SUMMARY

Accordingly, devices and methods for making textured breast implants areprovided. The devices and methods are more specifically directed toimplants with variable surfaces, including textured surfaces. Variabletextured breast implants are also provided.

The present invention provides methods for making prostheses, or softtissue implants, for example, implants suitable for use inreconstruction or augmentation of the human breast. Breast implants madein accordance with the methods and devices described herein, generallycomprise a soft elastomeric exterior and a gel or saline core orfilling. The exterior has a variable texture for enhancing adhesion oftissue in desired regions of the implant.

In one aspect, methods are provided for texturing a breast implantexterior surface. The exterior of a breast implant can be generallydefined by a posterior surface which generally faces the chest wall, andan anterior surface which faces away from the chest wall and when theimplant is implanted in a breast. Conventionally, both the anteriorsurface and the posterior surface are identical to each other in termsof surface texture or lack thereof. In accordance with one aspect of theinvention, the devices and methods are useful for making a breastimplant having a posterior surface and an anterior surface that aredifferent from one another, for example, have different textures fromone another, or have texture on one surface and relative lack of textureon another surface.

In another aspect, a device for use in molding a variable texturedbreast implant is provided. The device generally comprises a memberstructured to engage a breast implant mandrel having a molding surfaceand a stem depending therefrom. The member includes a base-engagingdistal portion and a stem-engaging proximal portion depending from thebase-engaging distal portion. The base-engaging distal portion comprisesa base-engaging surface, and an aperture defined in the base-engagingsurface for receiving the stem of the mandrel when the mandrel is seatedin the base engaging portion. The member is made of a material and isstructured such that, when coupled with a breast implant mandrel, itprovides a barrier for preventing silicone dispersion and/or texturingparticles from contacting a portion of the mandrel when the mandrel isimmersed in a silicone dispersion and/or texturing particles. In oneembodiment, the member includes a proximally sloping rim circumscribingthe base-engaging surface. The member may be made of any suitablematerial, for example, but not limited to an elastomeric material suchas a silicone elastomer, or alternatively, a relatively rigid polymericmaterial, such as Acetal.

In one aspect the base-engaging surface of the member is configured orshaped to conform to a base region of breast implant mandrel. In oneembodiment, the base-engaging surface is a substantially conicallyshaped surface. The aperture may be disposed generally in the center ofthe conically shaped surface.

In one embodiment, the proximally sloping rim slopes at an anglesubstantially equal to a slope of the mandrel surface, such that theproximally sloping rim substantially aligns with the mandrel surfacewhen the mandrel is seated in the base-engaging portion.

In some embodiments, the proximally sloping surface has a slope anglerelative to a plane perpendicular to the longitudinal axis of themember, the slope angle being between about 20° and about 70°, forexample, between about 30° and about 60°. In one embodiment, the slopeangle is about 45°.

In another aspect of the invention, a breast prosthesis shell isprovided that includes a variable textured surface, for example, a shellmade using the methods and devices described herein.

In yet another aspect of the invention, a method for making a texturedbreast implant is provided, the method comprising the steps of securingthe device described elsewhere herein to a breast implant mandrel coatedwith a tacky elastomer, contacting the tacky elastomer with texturingparticles, for example, by immersing the breast implant mandrel anddevice secured thereto into a bath of texturing particles; removing thedevice from the mandrel; curing the tacky elastomer; and removing thetexturing particles to obtain a breast implant shell having a firsttextured surface and a second surface, for example a smooth surface,different from the first textured surface.

In one aspect of the invention, a breast implant is provided, theimplant comprising an elastomeric envelope having a posterior surfacedefined by a cellular texture having a first depth defined byinterconnected pores, the first depth being at least three pores indepth, and an anterior surface defined by an open cell texture having asecond depth defined by pores, the second depth being about one pore indepth.

In yet another aspect of the invention, an assembly is provided for usein making a variable textured breast implant, the assembly comprising amandrel having a molding surface and a stem depending therefrom and adevice for receiving the mandrel as disclosed elsewhere herein.

In another aspect of the invention, a breast implant is provided havingmore significant texturing on the front, or anterior side, of theimplant, and is reduced or omitted on the back, or posterior side of theimplant. It has been discovered that this structure and arrangement ofsurface texturing provides a breast implant with certain surgical andmedical advantages. In addition, the implant may provide a reduced riskof capsular contracture relative to conventional implants.

For example, when placed subglandularly, the implant structure willprovide enhanced tissue adherence on front of the implant and to reducedtissue adherence to tissue, for example, muscle tissue, on the back ofthe implant.

Each and every feature described herein, and each and every combinationof two or more of such features, is included within the scope of thepresent invention provided that the features included in such acombination are not mutually inconsistent.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects, features and advantages of the presentinvention may be more clearly understood with reference to the followingDetailed Description when considered in conjunction with theaccompanying Drawings, of which:

FIG. 1 is a perspective view of an assembly for use in making a variabletextured breast implant;

FIG. 2 is a view similar to FIG. 1, with a portion of the assembly shownin cross-section;

FIG. 3 is a perspective view of the assembly shown in FIG. 1, as beingused to form a variable textured breast implant shell;

FIG. 4 is a partial cross-sectional side view of the assembly as beingused to form a variable textured breast implant shell, as shown in FIG.3; and

FIG. 5 is a side view of a breast implant formed with the assembly shownin FIG. 3;

FIG. 6 is a cross sectional view of another implant formed with theassemblies, devices or methods of the invention;

FIGS. 7, 7A and 7B illustrate a method of the invention for producing avariable textured breast implant;

FIGS. 8, 8A and 8B illustrate another method of the invention forproducing a variable textured breast implant; and

FIGS. 9, 9A and 9B illustrate yet another method of the invention.

DETAILED DESCRIPTION

Turning now to FIGS. 1 and 2, an assembly of the invention is showngenerally at 10, and comprises a mandrel 12, and a device 20 for use inmolding a variable textured breast implant when used in conjunction withthe mandrel 12.

The mandrel 12 may be similar or identical to a standard, conventionalbreast implant mandrel 12, generally including a shaped form 21 defininga molding surface 22 having a proximal region 24 and a distal region 26which together define a configuration of a breast implant shell 100(shown, for example, in FIG. 6) to be molded therefrom. The mandrelfurther includes a stem 28 secured to the form 21 and depending in aproximal direction, for enabling manipulation of the mandrel 12 duringthe molding process.

In the shown embodiment, device 20 comprises a member 32 structured toengage a breast implant mandrel, such as mandrel 12. Member 32 generallyincludes a base-engaging distal portion 34 and a stem-engaging proximalportion 36 depending from the base-engaging distal portion 34. Thebase-engaging distal portion 34 comprises a base-engaging surface 38, anaperture 40 defined in the base-engaging surface 38, and a rim 44circumscribing the base-engaging surface 38. The base engaging surface38 has a shape in conformance with a portion of the shaped form 21, forexample, is conically shaped as shown most clearly in FIGS. 1, 2 and 4.

Turning briefly as well to FIG. 4, the stem-engaging proximal portion 36of member 32 is structured to receive the stem 28 of mandrel 12 whenmandrel 12 is seated in the base-engaging portion 34. As shown in FIG.4, member 32 provides a shield or barrier for preventing siliconedispersion and/or texturing particles from contacting or adhering to aportion of the mandrel 12, for example, mandrel proximal region 24, whenthe mandrel 12 is immersed in a silicone dispersion and/or texturingparticles 102.

Member 32 is configured and structured to provide a compliant, matingseal between a silicone elastomer covered mandrel 12 and base-engagingsurface 38. Turning back now to FIG. 2, rim 44 comprises a surface 46which slopes in a proximal direction as shown, having a slope angle (α)relative to a plane perpendicular to the longitudinal axis X of themember 32. The slope angle is between about 20° and about 70°, forexample, between about 30° and about 60°. In one embodiment, the slopeangle (α) is about 45°.

Turning specifically to FIG. 2, configuration of rim 44, having a sharpedge 44 a and concave region 44 b, may be configured to enhance sealingbetween member 32 and mandrel 12, for example, by providing a higherunit pressure against mandrel. The radius of curvature (R) of concaveregion 44 b, in the shown embodiment, is about 0.34″.

Slope angle α may function in part to facilitate effective draining ofparticles and prevent pooling of texture particles 102 along rim 44during the texturing process described hereinafter. For example, theproximally sloping rim 44 slopes at an angle substantially equal to aslope of the mandrel surface, such that the proximally sloping rimsubstantially aligns with the mandrel surface when the mandrel is seatedin the base-engaging portion, as shown most clearly in FIG. 4.

In one aspect of the invention, methods are provided for making avariable textured breast implant shell, for example, using the assembly10 shown in FIGS. 1 and 2.

In one embodiment useful for making a breast implant 100 having atextured surface on one side thereof and a smooth or untextured surfaceon an opposing side thereof, such as shown in FIG. 5, the method mayinclude providing a breast implant mandrel 12 having a cured siliconeelastomer coating thereon, securing the device 20 to the mandrel 12,coating the breast implant mandrel with a tacky elastomer, such as asilicone dispersion, for example, by dipping, spraying or other suitablemeans, and immersing the breast implant mandrel 12 and device 32 securedthereto into a bath of texturing particles. Texturing particles may beany suitable texturing particles known in the art, for example, saltcrystals, sugar crystals, starch beads, dissolvable polymeric beads,etc. Certain advantageous texturing particles useful with the presentdevices and methods are described in U.S. patent application Ser. No.13/104,811 filed on May 21, 2012, and U.S. patent application Ser. No.13/631,091, filed on Sep. 28, 2012, the entire content of each of theseapplications incorporated herein by this specific reference.

The assembly 10 at this point in the process is illustrated in FIGS. 3and 4, which show mandrel 12 and member 32 having an elastomerparticle-coated construction 48, as shown. The application of elastomerand particles can be repeated to achieve a desired thickness oftexturing on the shell. The assembly 10 is then placed under curingconditions, for example, is placed into a curing chamber, for example, aheated oven, for a suitable amount of time, to cause at least partialcuring of the elastomer coating. In this step, in some embodiments, thetexturing particles may begin to melt and adhere to one another, whichwill provide an open cell, or interconnected cell texture when theparticles are removed (see briefly, for example, FIG. 6).

Further, in some embodiments, the curing step is performed so that theelastomer is not fully cured at this point, but remains somewhat softand/or tacky. This may be helpful to facilitate separation of themandrel 12 from the member 32. Further still, optionally, a cuttingimplement may be used to sever the elastomer along a juncture 50 betweenthe mandrel 12 and member 32, to produce a clean seam 50 a betweentextured and untextured portions of the implant shell 100, for example,as shown in FIG. 5.

After the curing step, the texturing particles may then be removed fromthis construction 48 by any suitable means, for example, rinsing ordissolving in a solvent, leaving a textured porous surface. Member 32 isremoved from the mandrel 12, for example, by sliding member 32 off ofmandrel stem 28, and the elastomer/particle layered construction 48 iscarefully stretched apart from and removed from the shaped form 21,resulting in a hollow, flexible envelope. In some embodiments, theparticle removal step may be performed after the construction 48 isremoved from the mandrel. Once the particles are removed from theelastomer, the construction 48 is useful as a breast implant shell 100having one side, for example an anterior side 52 that is textured withcavities remaining from the removed particles, and an opposing side, forexample, a posterior side 54, that is smooth and untextured, such asshown in FIG. 5. Finishing steps that are conventional may be performedto seal the aperture left from the mandrel stem with a patch, forexample, and the shell 100 may be filled with saline or gel in anyconventional manner.

The present invention can be modified to achieve a number of differenttypes of breast implant shells having different forms of variabletexture. For example, in some embodiments, a breast implant shell 110,shown in FIG. 6, having a first textured surface 66 produced by multiplelayers, for example, three or more layers of particles/elastomer, and asecond textured surface 68 produced by relatively fewer layers, forexample, one layer, of particles/elastomer, may be provided. This may beaccomplished substantially as described elsewhere herein, with onedifference being that member 32 may be installed on mandrel 12 when themandrel already includes a particle/elastomer covered surface, forexample, a single layer of particles on the entire implant surfaceincluding the portion covered by the member 32. After installing of themember 32, further layers of particles and elastomer may be layered ontothe mandrel/member assembly, while the member 32 is in place providing ashield from elastomer and particle application on exposed portions.

The resulting shell 110, after removal of particles, is shown incross-section in FIG. 6. In this embodiment, the first textured surface66 defines the anterior surface of the shell, outwardly facing breasttissue when implanted, and the second textured surface 68 defines theposterior surface of the shell, rearwardly facing the chest wall.

Other exemplary methods of the invention are shown as Flow Diagrams inFIGS. 7-9. The method shown in FIG. 7 (FIGS. 7A and 7B) can be used tocreate a breast implant shell having a single layered texture on oneside of the implant, e.g. the posterior surface, and a double layeredtexture on another side of the implant, e.g. the anterior surface. Themethod shown in FIG. 8 (FIGS. 8A and 8B) can be used to create a breastimplant shell, for example, shell 100, having a smooth surface on oneside of the implant, e.g. the posterior surface, and a triple layer oftexture on another surface, e.g. the anterior surface. The method shownin FIG. 9 (FIGS. 9A and 9B) can be used to create an implant shellhaving as single layer of texture on one surface and a double, triple,or greater number of layers of texture on an opposing surface, forexample, such as implant 110 shown in FIG. 6.

In yet another aspect of the invention, a breast implant is providedhaving a variable textured surface that provides certain advantages overconventional breast implants, for example, fully textured implants. Theimplant may be manufactured using the assemblies, devices and methodsdisclosed herein, or other methods known in the art.

The implant generally comprises an anterior surface having amultilayered texture defined by open cell pores of a first depth, and aposterior surface having a single layered texture defined by open cellpores of a second depth that is less than the first depth.

For example, in some embodiments, the anterior surface of the implantincludes a deeper texturing, for example a depth of porosity that isgreater than texturing on the rear or posterior surface of the implant.Implant 110, shown in FIG. 6, provides an example of this embodiment ofthe invention. For example the anterior surface 66 of the implantcomprises two, three, four, five or more layers of texturing, made forexample, by alternating layers of texturing particles with siliconedispersion layers, during the manufacturing process; and the posteriorsurface 68 includes one layer of texturing made by application of asingle layer of texturing particles (e.g. not alternating multiplelayers of particles and elastomer during manufacturing).

Alternatively, the anterior surface includes two or more layers oftexturing and the posterior surface has less or no texturing (smooth).

In any of the aforementioned embodiments, the depth of the porousstructure of first surface region may be a relatively deep porousstructure, for example, a porous structure that is multiple pores deep,for example a depth of porosity that is about 3, 4 or more pores indepth, such as shown in FIG. 6.

For example, the anterior region of the shell may be defined by a firsttextured surface defined by multiple layers of interconnected pores, forexample, about two to about five layers of interconnected pores. Thelayers of interconnected pores may extend a first depth, for example, adepth of between about 0.2 mm to about 5.0 mm into the shell outersurface. In contrast, the posterior region of the implant may be definedby smooth, non-textured surface, or a less textured surface, forexample, a substantially non-porous surface, for example, a dimpledsurface.

In some embodiments, the anterior surface is defined by multiple layersof pores, while the posterior surface is defined by multiple layers ofpores that extend less deeply into the shell than the anterior surfacepores. In other words, in this embodiment, both the anterior andposterior of the implant are defined by a porous, textured structure,but the anterior surface is defined by a less deeply textured porousstructure than the posterior surface.

In some embodiments, the pore size, for example, the pore diameter, isbased on the size of the particles used to form the texture. In someembodiments, about 50%, or about 70% or about 80% or about 90% of theparticles used to form the texture are generally spherical beads, forexample, dissolvable polymer, sugar, salt or other dissolvable materialbeads, having a diameter of between about 100μ to about 1000μ, forexample, about 200μ to about 800μ, for example, or about 300μ to about700μ, or about 400μ to about 600μ in diameter.

In one embodiment, about 90% of the particles used to form the pores arebetween about 420μ to about 595μ in diameter.

In one embodiment, a variable textured breast implant is provided, theimplant comprising an elastomeric shell comprising an anterior regionand a posterior region, wherein the anterior region and posterior regiondefine an outer surface of the shell, the anterior region defined by afirst textured surface conducive to tissue ingrowth and further definedby interconnected pores wherein the interconnected pores of the firsttextured surface extend at least about two to about five pore diametersdeep into the shell outer surface, and the posterior region defined by asurface less conducive to tissue ingrowth than the first texturedsurface.

In some embodiments, the first textured surface comprises multiplelayers of said interconnected pores extending to a depth of betweenabout 0.2 mm to about 5.0 mm into the shell outer surface. In anotherembodiment, the first textured surface extends a depth of between about0.8 mm to about 3.0 mm. In some embodiments, the pores of the firsttextured region are relatively uniform in size. In some embodiments, thepores of the first textured region are relatively uniform in size andhave a diameter of between about 100μ to about 1000μ, or between about200μ to about 800μ, or between about 300μ to about 700μ, or betweenabout 400μ to about 600μ. For example, at least about 70% of the pores,or at least about 90% of the pores of the first textured region have auniform diameter in one of these ranges. For example, in a specificembodiment, at least about 90% of the pores of the first textured regionhave a diameter of between about 400μ to about 600μ.

In accordance with one aspect of the invention, the surface of theposterior region is a smooth, non-textured surface. In anotherembodiment, the surface of the posterior region is defined by a dimpledsurface. In some embodiments, the surface of the posterior region isdefined by pores extending no greater than about one pore deep into theshell outer surface.

In these embodiments, the present implant 110 may provide certainsurgical advantages over prior art implants. For example, when itbecomes desirable or necessary to remove the implant from a patient, theimplant can be removed with less trauma to the patient relative toconventional implants. For example, during surgical removal of theimplant from a patient, the anterior portion of the implant can bereadily accessed through the original incision, for example aninframammary incision. The integrated tissue on the posterior surface ofthe implant can be visualized and surgically separated from the moreheavily or deeply textured surfaces of the implant. The posterior sideof the implant, which is by nature more difficult to surgically access,can be separated from the tissue by simple finger dissection or peelingaway of the implant due to its minimal tissue integration.Aesthetically, tissue adherence advantageously can maintain a desiredposition of the implant in the breast, preventing rotation or migration,and maintaining correct orientation of anatomically shaped implants.

Unless otherwise indicated or otherwise clearly contradicted by context,combinations of the above-described elements in all possible variationsthereof are contemplated to be included within the scope of theinvention.

What is claimed is:
 1. A variable textured breast implant for placementin a breast, the implant comprising: an elastomeric shell comprising ananterior region and a posterior region, wherein the anterior region andposterior region define an outer surface of the shell; the anteriorregion defined by a first textured surface defined by interconnectedpores wherein the interconnected pores of the first textured surfaceextend at least about two to about five pore diameters deep into theshell outer surface; and the posterior region defined by a surface lessconducive to tissue ingrowth than the first textured surface.
 2. Theimplant of claim 1 wherein the first textured surface comprises multiplelayers of said interconnected pores extending to a depth of betweenabout 0.2 mm to about 5.0 mm into the shell outer surface.
 3. Theimplant of claim 13 wherein the first textured surface extends a depthof between about 0.8 mm to about 3.0 mm.
 4. The implant of claim 1wherein the pores of the first textured region are relatively uniform insize.
 5. The implant of claim 1 wherein the pores of the first texturedregion are relatively uniform in size and have a diameter of betweenabout 100μ to about 1000μ.
 6. The implant of claim 1 wherein at leastabout 70% of the pores of the first textured region have a diameter ofbetween about 100μ to about 1000μ.
 7. The implant of claim 1 wherein atleast about 90% of the pores of the first textured region have adiameter of between about 100μ to about 1000μ.
 8. The implant of claim 4wherein the pores of the first textured region have a diameter ofbetween about 200μ to about 800μ.
 9. The implant of claim 4 wherein thepores of the first textured region have a diameter of between about 300μto about 700μ.
 10. The implant of claim 4 wherein the pores of the firsttextured region have a diameter of between about 400μ to about 600μ. 11.The implant of claim 1 wherein at least about 90% of the pores of thefirst textured region have a diameter of between about 400μ to about600μ.
 12. The implant of claim 1 wherein the surface of the posteriorregion is a smooth, non-textured surface.
 13. The implant of claim 1wherein the surface of the posterior region is defined by a dimpledsurface.
 14. The implant of claim 1 wherein the surface of the posteriorregion is defined by pores extending no greater than about one pore deepinto the shell outer surface.
 15. A variable textured breast implant forplacement in a breast, the implant comprising: an elastomeric shellcomprising an anterior region and a posterior region, wherein theanterior region and posterior region define an outer surface of theshell; the anterior region defined by a first textured surface definedby layers of interconnected pores extending a first depth into the shellouter surface; and the posterior region defined by a second texturedsurface defined by pores extending to a second depth of less than saidfirst depth.
 16. The implant of claim 15 wherein the first depth is adepth of between about 0.2 mm to about 5.0 mm into the shell outersurface.
 17. The implant of claim 15 wherein the pores of the firsttextured surface and the pores of the second textured surface aresubstantially the same in diameter.
 18. The implant of claim 17 whereinthe pores of both the first textured surface and the second texturedsurface generally have a diameter of between about 100μ to about 1000μ.19. The implant of claim 17 wherein at least about 70% of the pores ofboth the first textured surface and the second textured surface have adiameter of between about 100μ to about 1000μ.
 20. The implant of claim17 wherein the pores of both the first textured surface and the secondtextured surface generally have a diameter of between about 400μ toabout 600μ.
 21. The implant of claim 17 wherein at least about 90% ofthe pores both the first textured surface and the second texturedsurface have a diameter of between about 400μ to about 600μ.
 22. Avariable textured breast implant for placement in a breast, the implantcomprising: an elastomeric shell comprising an anterior region and aposterior region, wherein the anterior region and posterior regiondefine an outer surface of the shell; the anterior region defined by afirst textured surface conducive to tissue ingrowth and further definedby about two to about five layers of interconnected pores extending afirst depth of between about 0.2 mm to about 5.0 mm into the shell outersurface, wherein at least about 90% of the pores have a diameter ofbetween about 400μ to about 600μ; and the posterior region defined by asmooth surface.